Modular Apparatus for Delivery of Fluid Materials

ABSTRACT

Apparatuses and methods for delivery of fluid materials, particularly multi-part fluid materials, including modular apparatuses in which various components are maintained separately until ready for use. Each fluid component is maintained in a separate housing until mixing of the fluid components is desired. Maintaining components separately until use allows for proper filling, sterilization, packaging and storing until use.

FIELD OF THE INVENTION

The present invention relates to apparatuses and methods for delivery offluid materials, particularly multi-part fluid materials. The inventionmaintains each fluid component in a separate housing until mixing of thefluid components is desired. Further, the invention allows for variouscomponents to be kept separate until use is desired, and then eachcomponent may be assembled quickly and easily to form the applicator.

BACKGROUND

Some biological components, including multi-component materials such asfibrin and its base components (fibrinogen and thrombin), are delicatematerials and cannot tolerate processing with conventional sterilizationtechniques without being significantly compromised or even destroyedwhen they are in solution. Traditionally, such biological components aremanufactured in two packages, the first including a terminallysterilized delivery device, and the second being an aseptically filledvial with non-sterile exterior. While this allows for control of theproducts, unfortunately the biological materials must then betransferred into the applicator at the time of use. This multi-stepprocess requires some unusual coordination between sterile andnonsterile surgical staff, and may lead to errors or anxiety on the partof that staff. Further, the transfer of materials into a delivery deviceitself lends itself to potential mistakes and leakage/spillage ofmaterial. It would be more desirable for users if the biologicalproducts can be delivered in a pre-loaded and sterilized applicator,such that the entire contents could be deposited on the sterile fieldwithout the need for further preparation steps.

It is one objective of the present invention to provide a product withthis capability to deliver materials pre-loaded and ready for dispensingwithout filling or loading materials into an applicator. Some two-partmaterials, such as fibrin sealants, are highly reactive with oneanother, and it is critical that even the slightest amount ofcross-contamination between first and second materials be prevented.Cross-contamination would not only render the device useless, but wouldrequire a costly decontamination of the assembly area. To protectagainst such cross-contamination, it may be desired that each reactivematerial be loaded and sealed in a separate vessel, and then broughttogether into a unified device at the time of use without having totransfer the fluid materials into a separate vial or barrel. It is afurther objective of the invention to provide for a means of assemblythat minimizes potential for cross-contamination.

Further, it is important that the components of the delivery assembly besterile inside and outside. Even with pre-sterilization of allcomponents entering a filling region, the ability to claim sterility onthe exterior of product has traditionally been questionable. It istherefore helpful and is one additional objective of the invention tosubject the entire exterior of the device to low level of radiationenergy, such as with an electron-beam, after filling with biological orreactive components. This poses a number of unique design challenges,since the exterior surfaces of the device that can be touched by theuser, or that come into contact with fluids inadvertently leaked orspilled on the device must be “visible” to the electron beam, since thebeam is propagated in a purely linear manner from its source. When suchsterilization techniques are used, it is particularly helpful that therebe no shadowing, cracks, steps, or crevasses on the device that blockline of sight of the beam to these surfaces.

SUMMARY

The invention includes an apparatus for delivery of a biological fluid,particularly a modular apparatus with various components, which may beprovided by themselves or all provided together. The delivery device mayinclude an applicator component, the applicator component including: ahousing, the housing including a keyfit region; first and second counterbore regions within the housing, each counter bore region having agenerally cylindrical shape and being aligned such that the central axesof each counter bore region are parallel with each other; and first andsecond delivery lumens, each delivery lumen having an insertion end anda delivery end, the insertion end of each lumen including a needledcannula within one of the counter bore regions.

The delivery device also may include a fluid housing component,including: at least two cylindrical barrels having a dispensing end anda plunger receiving end; at least two polymeric caps, where onepolymeric cap is fit onto a dispensing end of a cylindrical barrel; abridge having an open interior, which fits securely on the dispensingend of the at least two cylindrical barrels, the bridge having a keyfitregion that fits into the keyfit region of the housing, where securementof the fluid housing component with the applicator component aligns oneneedled cannula with the interior of one cylindrical barrel by piercingone polymeric cap.

The delivery device may include a plunger component, including: at leasttwo cylindrical plunger components having a first end and second end,each sized such that the first end may be inserted into the plungerreceiving end of one of the barrels; an open flange component throughwhich the cylindrical components may be slidably inserted; and asecurement feature to secure the dispensing end of the barrels in theopen flange component.

The present invention further may include a kit, including at least oneof the applicator component, fluid housing component and plungercomponent. The kit may include at least two of the aforementionedcomponents, or it may include all three components. The kit may furtherinclude instructions for use.

The present invention also may include a method of dispensing at leasttwo reactive fluids simultaneously. The method includes the steps ofproviding an applicator component, providing a fluid housing componentand providing a plunger component, securing the applicator component tothe fluid housing component, such that each needled cannula pierces oneelastomeric cap; securing the plunger component to the fluid housingcomponent; and depressing the plunger, such that each plunger componentmoves one of the pistons into one of the barrels, thereby forcing eachof the first and second biological fluids through one of the deliverylumens.

Another aspect of the invention includes only a fluid housing cartridgefor use in a modular delivery device, including at least two cylindricalbarrels having an open interior separated by a dispensing end and aplunger receiving end; at least two elastomeric caps, where oneelastomeric cap is fit onto the dispensing end of one cylindricalbarrel; at least two pistons having a generally cylindricalconfiguration, with a sealing surface on the outer circumference and agenerally flat proximal surface, one piston being placed into thedispensing end of one cylindrical barrel; and a bridge having an openinterior, which fits securely on the dispensing end of the at least twocylindrical barrels so as to hold the at least two cylindrical barrelsin a substantially parallel configuration.

It may be desired to include a method of sterilizing a pre-filled fluidhousing component. The fluid housing component includes at least onebarrel, which is filled with a fluid material. The barrel may be sealedby placing a pierceable cap on a distal end of the barrel and fitting apiston within the interior of the barrel at the proximal end of thebarrel. The piston is placed in a substantially flush configuration withthe proximal end of the barrel, and then the sealed barrel is exposed tosterilization methods, such as radiation energy.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 depicts a view of a delivery apparatus in an assembledconfiguration.

FIG. 2 is a close-up view of an applicator component.

FIG. 3 is a see-through view of the applicator component of FIG. 2.

FIG. 4 is a perspective view of the applicator component of FIG. 2.

FIG. 5 is a close-up view of a fluid housing component with two barrels.

FIG. 6 is an expanded view of the fluid housing component of FIG. 5.

FIG. 7 is a close-up and expanded view of a plunger component.

FIG. 8 is an expanded view of various components forming a deliveryapparatus.

FIG. 9 is an expanded view of a plunger component and fluid housingcomponent in unattached configuration.

FIG. 10 is a close-up view of an applicator component with a see-throughhousing and a fluid housing component in attached configuration.

DETAILED DESCRIPTION

The present invention relates to a modular delivery device, whichincludes a plurality of separate components that are capable of beingattached to each other and form a resulting fluid delivery assembly. Inparticular, the delivery device is suitable for delivery of fluidmaterials, including the simultaneous delivery of a plurality ofbiological and/or reactable materials that are capable of reacting witheach other. For example, one particular combination of materials isfibrinogen and thrombin, which react together to form fibrin. Thefigures and description herein will refer to a delivery assemblyincluding two barrels, but it is to be understood that the assembly mayinclude only one barrel, or it may include three or more barrels. Aswill be understood through the description and Figures, for each barrel,there should be a separate fluid lumen, a separate cap, and a separatepiston. The delivery of the fluid materials should be simultaneous andallow for mixing at the site and immediately after exiting the device orsoon thereafter. The mixing can also be performed within the deliverytube, within the applicator component, or in a specialized mixing tipattached to the delivery tube. If only one barrel is used, the mixingstep may be omitted.

With reference to the Figures, a delivery device 10 of the presentinvention, when fully assembled, includes three components: anapplicator component 100, a plunger component 200, and a fluid housingcomponent 300. The invention may include any component separately, ormay include multiple components together. The invention further mayinclude a kit, including any one of the three components, any two of thethree components, or all three components. The three components aredesirably capable of being securely attached to each other, but it maybe desired that the components be detachable by a user if detaching isdesired. The present invention further relates to methods of assemblingand using delivery devices as described below.

FIG. 1 shows a fully assembled delivery device 10. As used herein, theterm “distal end” refers to the delivery end of the device, e.g., theend that the fluid/fluids leave the device for use. For ease ofunderstanding, the “distal end” of the assembled device is labeled inFIG. 1 as reference numeral 20. The “proximal end” of the deliverydevice is depicted as reference numeral 30, and refers to the oppositeend of the distal end, e.g., the end furthest away from the delivery endof the device, which typically includes a plunger or other device to bemanipulated by a user. Throughout the description below, the terms“proximal” and “distal” will refer to the aforementioned sides of thedevice and each component.

The device 10 includes, at its distal end (20), an applicator component100. Secured in fluid connection to the applicator component 100 is afluid housing component 300. Secured to the fluid housing component 300is a plunger component 200, such that the plunger component 200 islocated at the proximal end (30) of the device 10. As can be seen inFIG. 1, when fully assembled, the proximal end of the applicatorcomponent 100 is secured to the distal end of the fluid housingcomponent 300, and the proximal end of the fluid housing component 300is secured to the distal end of the plunger component 200. Eachcomponent may be separately formed, sterilized, packaged, and sold, asdesired.

One of the aspects of the invention is the ability to form threecomponents separately, subject them to individual sterilization methods,and provide them in a suitable, stabilized format for use by a user. Theapplicator component 100 and the plunger component 200 are desirablyfree of fluid materials, such as biological or reactable materials, andthus may be sterilized using conventional methods. The fluid housingcomponent 300 may be provided to users without any materials housedtherein, or it may be pre-loaded with the fluid materials to be used.Particularly if the fluid material(s) in the fluid housing component 300are biological materials, sterilization after loading the fluidmaterials is important. Although the invention refers to biologicalfluids, such as fibrin sealants, it may be understood that the presentinvention is useful for non-biological methods and fluids, such as, forexample, two-part epoxy or cyanoacrylate materials. Any multi-partmaterial may be used in the present invention, and for illustrativepurposes, the two-part system referenced herein describes delivery of afirst fluid and second fluid, such as thrombin and fibrinogen, which,when combined, form fibrin.

With reference to FIGS. 2-4, the applicator component 100 is described.The applicator component 100 includes a delivery component, which is anydevice useful to transport the fluid(s) from the device 10 to the targetarea. In use, the target area is any site at which the fluid(s) is to bedeposited, and in the case of biological sealants, may be a surgicalsite or the site of a wound. The applicator component may include anelongated tube 110, having a first end 114 (also known as a “distal” or“delivery” end) and a second end 112 located at the “proximal” end ofthe tube 110. The delivery tube 110 includes at least one internal fluidlumen, and in the case of a two-part delivery device, includes a firstfluid lumen 120 and second fluid lumen 130. The first and second fluidlumens 120, 130 run parallel to each other, spanning the entire lengthof the delivery tube 110. It is important that the fluid lumens 120, 130remain separated from each other until they reach the delivery site,since premature mixing of the fluid materials may cause undesirablereaction.

The applicator component 100 includes a housing 160, which isessentially hollow and is shaped to provide ergonomic support and use tothe end user. It should be noted that a full housing 160 is notrequired, but is desired. The housing 160 includes a first keyfitfeature 190 at its proximal end, which provides the ability to align theapplicator component 100 with the fluid housing component 300, as willbe described in greater detail below. As used herein, the “keyfit”assembly refers to a first keyfit feature, which is a generally openregion, which is sized and shaped to receive a second keyfit feature,which is an outwardly extending region. In the present invention, afirst keyfit feature 190 may be found on the housing 160, and a secondkeyfit feature can be found on the fluid housing component 300.

As can be seen in FIG. 3 (which is the applicator component 100 of FIG.2, depicted as having a see-through housing 160), the interior of thehousing 160 includes the first fluid lumen 120 and second fluid lumen130, separated from each other. At the proximal ends of the fluid lumens120, 130 are a first needled cannula 140 and a second needled cannula150, respectively. The fluid lumens 120, 130 are generally cylindricaland have an open interior. The needled cannula 140, 150 may have anyshape desired, with the proviso that the proximal end has a sharpenedfeature allowing it to pierce a cap, described below. The fluid lumens120, 130 have an open interior along the entire length from the needledcannula (140, 150) to the distal end 114 of the delivery tube 110.

The needled cannula 140, 150 are located in a fixed configuration inindividual open chambers 170A and 170B. Thus, first needled cannula 140is fixed in place substantially in the center of open chamber 170A,while second needled cannula 150 is fixed in place substantially in thecenter of open chamber 170B. As can be seen in the Figures, eachdelivery lumen 120, 130 may be linear as it travels through deliverytube 110, and then may travel along a non-linear path until each arrivesat the center of an open chamber 170. Open chambers 170A, 170B aregenerally cylindrical in shape and are configured to provide a snug fitwith fluid delivery caps around the internal surface of the openchambers 170A, 170B. Ribs 180, if used, may be disposed about theperiphery of the open chambers 170A, 170B, if desired. The interior ofthe housing 160 may include a raised rib 195, which is positioned, sizedand shaped to engage with a detent in the fluid housing component 300.

The delivery tube 110 and fluid lumens 120, 130 may be made of anymaterials, including polymeric materials or metallic materials. It isparticularly desired that the fluid lumens be made of materials such aspolyamides, polyurethanes, or other thermoplastics, although the lumensmay be coated or treated with additional materials as desired. Theneedled cannula 140, 150 should be sufficiently stiff and sturdy so asto be capable of piercing a polymeric or elastomeric material whenforced against that the polymeric or elastomeric material. The housing160 is desirably a rigid polymeric material, such as polycarbonate. Thedelivery tube 110 may have any desired length, as appropriate for theclinical application including from about 4 cm to about 180 cm. Eachfluid lumen 120, 130 may have any diameter desired, including about0.03″ to about 0.05″, although will generally be selected inconsideration of balancing and minimizing priming volume whilemaintaining suitable dispensing forces.

With reference to FIGS. 5 and 6, the fluid housing component 300 isdescribed. The fluid housing component 300 includes at least one, andpreferably two cylindrical barrels 310A, 310B each having an openinterior running along the central axis of each barrel 310. The barrels310A, 310B are aligned to be parallel to each other, with each centralaxis running parallel to each other. The barrels 310A, 310B should besubstantially the same size, shape, and length, and may include one ormore indicia thereon. The barrels 310A, 310B may be made of anymaterial, including glass, plastic, metal, and combinations thereof. Thebarrels 310A, 310B may each have a different diameter (not shown), ifdesired, so that the mixing of the components contained in the barrels310A, 310B may be performed in the volumetric ratio other than 1:1. Itmay be desired that the device and method described herein mix a greatervolumetric amount of fibrinogen than thrombin. For example, the mixingmay be performed in volumetric ratios of about 1:2, 1:3; or 1:4(thrombin:fibrinogen). The mixing may be performed in a volumetric ratioof about 1:5 (first fluid:second fluid), which may include about onepart of thrombin (or thrombin solution) mixed with about five parts offibrinogen (or fibrinogen solution). Each “part” described herein is byvolume.

As can be seen in FIG. 6, each barrel 310 is aligned in parallelconfiguration, but the barrels 310 need not be physically attached toeach other. Each barrel 310 includes a proximal end 320 (also referredto as a “plunger-receiving end”) and includes a distal end 330 (alsoreferred to as a “dispensing end”). Each of the proximal end 320 anddistal end 330 has an open interior, and the ends are in fluidconnection with each other through the open central axis of the barrel310. A separate, generally cylindrical piston 340 is provided for eachbarrel 310. The piston 340 is sized and shaped to be snugly but slidablyfit within the interior of the barrel 310, and desirably has a polymericor rubber elastomeric exterior circumference. The polymeric or rubberelastomeric exterior circumference is in contact with the circumferenceof the inside of a barrel 310, so as to act as a piston in a typicalsyringe-type assembly. Pushing the piston 340 through the center of thebarrel 310 provides the necessary pressure to evacuate fluid materialsfrom the inside of the barrel 310 out the dispensing end 330 of thebarrel. The piston 340 may have a substantially flat proximal surface,and may have no rod or other pushing means secured or attached theretoas in typical syringe assemblies. When fluid materials are housed in thebarrel 310, piston 340 is desirably fit into the barrel 310 such thatthe proximal end of the piston 340 is substantially flush with theproximal end 320 of the barrel 310. This flush fit aids insterilization, as it reduces shadowing, stepped regions, and unevensurfaces of components.

The fluid housing component 300 desirably includes a bridge 350, whichis a rigid component having a plurality of (at least two) openpassageways 355A/B that are aligned in parallel with each other. Thebridge 350 is sized and shaped to fit a portion of each barrel 310 so asto keep the barrels 310A/B in a secured position with respect to eachother. The bridge 350 includes a second keyfit feature 360 that is sizedand shaped to mate and engage with the first keyfit feature 190 of theapplicator component 100. As seen in the Figures, the first keyfitfeature 190 is depicted as a receiving region, and the second keyfitfeature 360 is an extended region, but it is understood that the two maybe reversed. The bridge 350 may include a detent 370, which is sized andshaped to mate with the raised rib 195 of the applicator component 100and form a secured connection between the two components. A gasket 380or other radial seal may be provided between the bridge 350 and thebarrels 310A/B.

At the distal end 330 of each barrel 310 is provided a polymeric orrubber cap 390A/B, which is sized and shaped to fit snugly and securelyover the open distal end 330 of each barrel 310. The cap 390 is to besecured to the distal end 330 of the barrel 310 in such a fashion thatany material contained within a barrel 310 is secured in a leak-freeenvironment. That is, the cap 390 secures the fluid material within thebarrel 310. The cap 390 has a distal surface that is capable of beingpierced with a needle. When the barrels 310 are secured in the bridge350, the caps 390 are contained within the bridge 350. Morespecifically, one cap 390 is disposed within one of the open passageways355 of the bridge 350. When two barrels 310 are used, first cap 390A isplaced and secured within first open passageway 355A, and second cap390B is placed and secured within second open passageway 355B.

When the delivery device 10 is assembled, the cap 390 is snugly fitwithin the open chamber 170 of the applicator component 100, thusproviding a tight-fit seal and reducing the tendency of fluid materialto leak once the cap 390 is pierced with the needled cannula (e.g., 140,150) of the applicator component 100 and especially once the dispensingof fluid material is performed via advancement of the piston 340 withinthe barrel 310. To aid in forming a tight, leak-free seal, the cap 390may include an outwardly extending radial rib 395, extending about andaround the external circumference of the cap 390. The radial rib 395 iscompressed against the interior side wall of the open chamber 170 whenconnected, forming a secure, fluid-tight seal and preventing leakage outof the chamber even if slight leaking occurs out from the opening in thecap.

It is desired that each of the parts of the assembled device 10 beconnected in a gapless, fluid-tight configuration, so as to prevent orreduce the likelihood of accidental leakage of the fluid material(s)contained within any barrel 310 or during operation of the device. Theuse of seals, gaskets and tight configurations aids in securing thefluid materials.

In use, the keyfit engagement between applicator component 100 and fluidhousing component 300 only allows the components 100, 300 to be securedto each other in one configuration. This proper assembly forces eachneedled cannula (e.g., 140) to be connected in a single orientation witha single barrel 310, and specifically into the pierced cap 390 on thatbarrel 310. This keyfit engagement ensures proper orientation and,importantly, proper piercing of the cap(s) 310 during use. This alsoallows for ease of replacing the components, in cases where the userwishes to replace the applicator component 100 or fluid housingcomponent 300 mid-procedure.

FIG. 7 depicts a plunger component 200, which may be useful in thepresent invention. The plunger component 200 includes a plunger 210,which includes a plurality of pushing rods 220A/B, which may have anycross-sectional configuration, including cylindrical, square ordiamond-shaped, or any other geometric cross-section. Desirably, thereis one pushing rod 220 for every barrel 310 in the assembly 10. Thepushing rods 220 may include one or more notches 230 on its outersurface, which may be used with a friction element so as to preventinadvertent withdrawal of the plunger 210. The pushing rods 220 may beconnected to each other at their proximal end via a depressor 240 toensure depression of the rods 220 simultaneously. The depressor 240 maytake any shape or configuration, and desirably is designed such that auser may place his or her thumb or fingers on the depressor 240comfortably. The plunger component 200 includes a finger flange 250,which has a generally open interior and is sized and shaped to allow thepushing rods 220 to slidably move within its interior chambers 260A/B.The interior chambers 260A/B extend throughout the entire length of thefinger flange 250 and hold the rods 220 in an aligned configuration.

The finger flange 250 may include an internal notch or friction element270, which is disposed at a location selected to engage rods 120 suchthat motion of the rods is slightly restricted and cannot move under theinfluence of gravity alone. The finger flange further includes notch230. The engagement of notch 230 and friction element 270 is such thatthe pushing rod 220 may be pushed distally but is restricted from beingremoved in the proximal direction, preventing rods 120 from beinginadvertently detached from the finger flange. Finger flange 250 mayalso include at least one snap engagement means 280 at one or eachinterior chamber 260, which is designed to engage with a barrel 310,securing the barrel 310 in the interior chamber 260 when connected.Finger flange 250 may also include an ergonomic holder region 290 forease of use. In the Figures, pushing rods 220A/B are not attached topistons 340 A/B, thereby preventing movement of pistons in proximaldirection if pushing rods 220 A/B are pulled in the proximal direction.

As can be seen in FIG. 8, the three components (100, 200, 300) of theassembled delivery device 10 are axially aligned with each other, suchthat the distal end of the fluid housing component 300 can be insertedinto the proximal end of the applicator component 100, and the proximalend of the fluid housing component 300 can be inserted into the distalend of the plunger component 200. When each component is secured in thisfashion, the various seals, friction fits and snap fits serve tomaintain the completed delivery device assembly 10 in a substantiallyfluid-tight and secure configuration.

As can be seen in FIG. 9, the proximal end 320 of each barrel 310 may beinserted into the distal end of the interior chamber 260 of the fingerflange 250, and may be snapped or secured into place via engagementmeans 280. Given the alignment of the pushing rods 220 through theinterior chambers 260, in this configuration, one pushing rod member 220is capable of being pushed axially into the open central region of onebarrel 310. In this fashion, the movement of a pushing rod 220 in thedistal direction causes the pushing rod 220 to engage the proximal sideof a piston 340, moving that piston 340 axially through the barrel 310,and thus forcing any fluid within the barrel 310 out the dispensing end330 of the barrel 310. In FIG. 9, two barrels 310A/B are inserted intothe plunger component 200, with a first barrel 310A inserted into afirst interior chamber 260A and a second barrel 310B inserted into asecond interior chamber 260B.

The use of pistons 340 and pushing rods 220 as separate components thatare not secured or attached to each other, as well as the flush fit ofthe piston 340 in the barrel 310, provides an additional benefit as itserves to eliminate potential shadowing of the barrel assembly (e.g.,barrel 310 and piston 340 contained therewithin), and further providesbearing/support surfaces to guide the plunger. In this configuration,the plunger component 200 is not actively secured or attached to apiston 340 with an undercut such that the piston 340 can be bothadvanced and retracted. In this unattached configuration, the pistons340 can only be advanced (in the distal direction). Of course, it isunderstood that the lack of attachment of rods 220 with the pistons 340may potentially allow free movement of the rods 220 in the proximaldirection, and thus engagement of the friction element 270 with rods 120may be useful in preventing inadvertent proximal movement of the plunger210. Further, the friction element 270 provides a degree of force ontothe pushing rod 220, such that exertion of some force (e.g., greaterthan mere gravity) by a user is required to push the plunger 210 in thedistal direction.

FIG. 10 shows the insertion of the distal end 330 of each barrel 310inserted into the applicator component 100, and more specifically intothe housing 160. FIG. 10 shows a see-through, transparent or translucenthousing 160, although it is understood that the housing 160 need not betransparent or translucent, and may be opaque or shaded. As can be seen,alignment of the applicator component 100 and fluid housing component300 is achieved by aligning each keyfit component 190, 360, and securingthe components in place via detent 370 and rib 195. The alignment due tothe keyfit components 190, 360 ensures proper engagement and piercing ofthe caps 390. Further, securement via detent 370 and rib 195 providessecure engagement and also may provide tactile or audible feedback to auser when the components are snapped together. Any snap-fit or othersecurement means may be used in place of a detent 370 and rib 195connection depicted in the Figures.

When a barrel 310 is inserted into the housing 160, the cap 390 isforced axially toward the distal end into open chamber 170, where itengages with needled cannula (e.g., 140). Due to the force imparted byinserting the barrel 310 into the housing 160, the needled cannula 140pierces the cap 390, thus providing a fluid channel from the interior ofthe barrel 310 to the interior of the fluid lumen (e.g., 120). Thenumber of barrels 310 inserted into the housing 160 should be equal tothe number of open chambers 170 and therefore equal to the number oflumens and needled cannulas. The force required to pierce the cap 390 isnot significant, but some degree of force is required to push the barrel310 into the housing 160 and cause piercing by the needled cannula (140,150).

As can be seen in FIG. 10, each cap 390 may include a radially extendingrib 395 about its external circumference, which is pressed snuglyagainst the interior surface of the open chamber 170. If used, theradially extending rib 395 forms a secure, fluid-tight seal, preventingfluid from being forced through the open chamber 170 and into thehousing 160. Pressure caused by the seal of the rib 395 and open chamber170 helps to reduce leakage through the cap, however, even if some fluidleaks through the cap (e.g., through the pierced region, around theoutside of a needled cannula), the presence of the radial seal willprevent further leakage into the housing 160. A gap may be presentbetween the far distal surface of the cap 390 and the interior of theopen chamber 170, where the gap may securely contain any leaked fluid.

The present invention allows for the fluid or fluids to be filled intothe fluid housing component 300 in a secure manner, with little risk ofcross-contamination and without the need to subject the other components(including applicator component 100 and plunger component 200) to thefluids. Through the present invention, the applicator component 100 andplunger component 200 can be separately made and stored, and may besterilized through traditional sterilization methods, including heat,chemical or radiation sterilization methods. They may be packaged orstored in sterile packaging until ready for use.

The fluid housing component 300 is a separate component including aplurality of barrels 310, desirably two barrels 310A and 310B. Thebarrels 310 may be individually filled with fluid materials, includingbiological material or other materials that are to be dispensed. Abarrel 310 can be filled to the desired amount, and then sealed byinserting a piston 340 into the proximal end 320 of the barrel 310 andplacing a cap 390 on the distal end 330 of the barrel 310. After fillingwith a desired amount of fluid, the piston 340 may be placed first, orthe cap 390 may be placed first, or each may be placed simultaneously.As noted above, the piston 340 is desirably placed such that theproximal end of the piston 340 is substantially flush with the proximalend 320 of the barrel 310, creating a proximal end assembly that haslittle to no ridges, gaps, steps or other such uneven features. Thebarrel 310 may be sterilized prior to filling if desired.

In a method of the present invention, a first barrel 310A may be filledwith a first reactive fluid composition, and a second barrel 310B may befilled with a second reactive fluid composition, where the first andsecond reactive fluid compositions react with each other to form a thirdcomposition. For example, the third composition may be a fibrin sealant,or alternatively, it may be an epoxy or acrylate. In instances where thethird composition is a fibrin sealant, the first reactive compositionmay be fibrinogen and the second reactive composition may be thrombin.The fluids used in the present invention may be a liquid, gel,suspension, gas, or combinations thereof. Each barrel 310 is filled to adesired amount of material, and each barrel 310 is then secured with apiston 340 and a cap 390. If more than one barrel 310 is to be used,each barrel 310 may additionally be secured together in a substantiallyparallel configuration with a bridge 350.

Again, it may be desired that the various components, excludingsensitive materials such as biological fluids, be pre-sterilized usingconventional means prior to filling with fluid materials. Suchconventional sterilization means include, for example, heat, radiation,steam, chemical or other treatment. The subsequent filling, sealing, andpackaging of the fluid housing component 300 desirably is conducted inan aseptic environment such as an isolator, so as to avoidcontamination. One of the benefits of the present invention is that thedevice may be further sterilized after filling is completed, even if thematerial to be filled is a sensitive biological material. In suchinstances, the filled fluid housing component 300 (which has been sealedwith piston 340 and cap 390) may be exposed to a treatment, such as byexposure to radiation energy to further sterilize the component 300 orits external surfaces, with no detrimental effects of the sterilizationtreatment upon the biological component contained therein. The radiationenergy may include a low energy electron beam, which provides additionalsterilization to the exterior of the component 300, avoiding possiblecontamination that occurred during the assembly process.

The geometry and materials of components of the fluid housing component300 are selected to assure that all exposed surfaces can be exposed tothe radiation energy. Furthermore, use of elastomeric components orsealing features (such as gasket 380) assures intimate seals betweencomponents, eliminating cracks and crevasses shielded from radiationenergy that might harbor contamination accessible to fluids in thesurgical field. Specifically, the seal from barrel 310 to bridge 350,the seal created by cap 390, and the seal created at the piston 340 onthe interior of the barrel 310 all aid in preventing damage orcontamination of the fluids within the barrel 310. It may be desiredthat the wall of the barrel 310 has a thickness of about 0.06″, which issufficient to prevent or reduce the likelihood of energy beingtransmitted through the wall and contact the fluid contained therein.

Once the fluid housing component 300 is filled and sealed, it can bepackaged and subjected to surface sterilization prior to passing out ofthe isolator, where it can be stored and ultimately provided to an enduser. Each barrel 310 may be stored separately, or a plurality ofbarrels 310 may be secured together via bridge 350 and stored as anassembly. If desired, the fluid housing component 300 may be stored in arefrigerated or controlled temperature environment, if the fluidmaterials housed therein require such temperature control. The fluidhousing component 300 may be provided to an end user by itself, or itmay be provided concurrently with the applicator component 100 and/orplunger component 200. For example, the three components (100, 200, 300)may be sold as a kit to be used by a user, and the kit may includeinstructions for use if desired. Alternatively, one or two of thecomponents may be provided to a user separately.

The present invention relates to methods of using the device describedabove. Each of the three main components of the modular device 10 (the“main components” is defined as including the applicator component 100,plunger component 200 and fluid housing component 300) may be providedto an end user at the same time or they may be provided separately. Anend user includes any individual or institution that seeks to deliver afluid, including biological fluids or other fluids described above. Theend user may be, for example, a medical professional, and the resultingcombination or mixture to be delivered may be fibrin (which rapidlyforms upon mixing of two fluids: fibrinogen and thrombin). Desirably,each of the three main components is sterilized and maintained in asterile packaging until ready for use by an end user. The fluid housingcomponent 300 is provided to an end user in a filled state, e.g., whereeach barrel 310 includes a desired amount of fluid material. Forexample, the fluid housing component 300 may include two barrels, 310Aand 310B, where first barrel 310A includes a desired amount of thrombinand second barrel 310B includes a desired amount of fibrinogen. Thebarrels 310A/B are sealed as described above and sterilized as describedabove, and secured to each other by inserting each barrel 310A/B into abridge 350. Providing sterilized and pre-filled barrels 310 is usefulbecause it allows quick, safe and easy use by an end user in a sterileenvironment with little risk of contamination.

Once the end user has the three main components, each main component canbe transferred to a sterile field. The applicator component 100 issecured to the fluid housing component 300, as described above, and theplunger component 200 is secured to the fluid housing component 300, asdescribed above. The order of assembly is not critical, and either theapplicator component 100 or the plunger component 200 may be securedfirst. As the fluid housing component 300 is secured into the housing160 of the applicator component 100, each needled cannula 140, 150engages one of the caps 390, piercing the cap 390 and providing a fluidconnection between the fluid lumens 120, 130 and the interior of thebarrel 310 with which it is connected.

Once assembled, the end user places the device 10 in a dispensinglocation, where the distal end 114 of the delivery tube 110 is at ornear the target delivery site. For example, the target delivery site maybe the site of a wound or surgical site to be sealed. The end user holdsthe delivery device 10 in his or her hands, and pushes the depressor 240in the distal direction. Pushing the depressor 240 moves the pushingrods 220 in the distal direction, where each pushing rod 220 engages theproximal end of a piston 340, forcing the piston 340 distally throughthe inside of a barrel 310. As noted above, since there is no attachmentbetween the pushing rod 220 and piston 340, the piston 340 can only bepushed in the distal direction, and cannot be withdrawn by the pushingrod 220 in the proximal direction. Further, given the tight seal createdaround the outer circumference of the piston 340, pushing the piston 340in the distal direction forces fluid from the inside of the barrel 310distally, where the fluid can be fed through the needled cannula (e.g.,140) and through fluid lumen (e.g., 120). Although desirably there is nofluid leakage through the pierced portion of the cap 390, it is possiblethat some fluid leakage may occur. For this reason, use of a seal formedby the sidewall of the open chamber 170 and a raised rib portion 395about the circumference of the cap 390 is useful, but not required.

As pressure is exerted on the piston 340, the fluid travels through thefluid lumen (e.g., 120), and out the distal end 114 of the delivery tube110. If a first fluid is contained in a first barrel 310A and a secondfluid is contained in a second barrel 310B, pushing the depressor 240pushes a first piston 340A and second piston 340B through first barrel310A and second barrel 310B, respectively. The first fluid travelsthrough first needled cannula 140, and through first fluid lumen 120,while the second fluid simultaneously travels through second needledcannula 150 and second fluid lumen 130. Each of the first and secondfluids is dispensed through the distal end 114 of the delivery tube 110simultaneously, where they are combined to form the ultimate reactiveproduct. If the first fluid is thrombin and the second fluid isfibrinogen, the simultaneous dispensing and mixing results in a fibrinsealant. The end user can dispense as much or as little fluid asdesired, and may end dispensing of the fluids by halting the exertion ofpressure on the depressor 240. The mixing of the first fluid and thesecond fluid may also be performed within the delivery tube, within theapplicator component, or in a specialized mixing tip attached to thedelivery tube (not shown). The various components of the above-describedinvention can be prepared separately, packaged separately and storedseparately until time of use. The invention allows for a safe, effectivemeans of providing a delivery assembly which is capable of beingsterilized while limiting risk of cross-contamination. The snap-fitengagement of the components allows for proper assembly by the end userwithout added steps or hassle and without risk of improper assembly. Thealignment of the needled cannulas and the caps provides for accuratepiercing of the caps, allowing entry of a fluid lumen into the interiorof a barrel and therefore providing a suitable fluid engagement of thecomponents. Further, given the ease and simplicity of attaching anddetaching the components, if a component needs to be replaced duringuse, it can easily be removed and replaced. For example, if the end userhas dispensed all of the fluids in the barrels, the end user need onlydetach the fluid housing component and replace it with a new, filledfluid housing component. This can be achieved quickly, safely andeasily.

The present invention may include any of the applicator component 100,fluid housing component 200, and/or plunger component 300, including anyof the variations and components described with reference to eachparticular component (100, 200, 300).

1. An apparatus for delivery of a biological fluid, comprising: a. anapplicator component, said applicator component comprising: i. ahousing; ii. first and second open chambers within said housing, eachopen chamber having a generally cylindrical sidewalls and being alignedsuch that the central axes of each open chamber are parallel with eachother; and iii. first and second fluid lumens, each fluid lumen havingan insertion end and a delivery end, said insertion end of each fluidlumen comprising a needled cannula disposed within one of said openchambers; b. a fluid housing component, comprising: i. at least twocylindrical barrels having an open interior separated by a dispensingend and a plunger receiving end; ii. at least two elastomeric caps,wherein one elastomeric cap is fit onto a dispensing end of onecylindrical barrel; iii. at least two pistons having a generallycylindrical configuration, with a sealing surface on the outercircumference and a generally flat proximal surface; iv. a bridge havingan open interior, which fits securely on the dispensing end of said atleast two cylindrical barrels; and c. a plunger component, comprising:i. at least two pushing rods having a first end and second end, eachsized such that the first end of one pushing rod may be inserted intothe plunger receiving end of one of said barrels; ii. an open flangecomponent through which said pushing rods may be slidably inserted; andiii. a securement feature to secure the dispensing end of said barrelsin the open flange component.
 2. The apparatus of claim 1, wherein saidhousing of said applicator component comprises a first keyfit region,said bridge comprises a second keyfit region, and said first keyfitregion and said second keyfit region are sized and shaped to mate witheach other.
 3. The apparatus of claim 1, wherein said applicatorcomponent and said fluid housing component can be secured to each otherby inserting said fluid housing component into the housing of theapplicator component.
 4. The apparatus of claim 3, wherein insertion ofthe fluid housing component into the housing of the applicator componentaligns a first needled cannula with the interior of a first cylindricalbarrel by piercing a first elastomeric cap.
 5. The apparatus of claim 1,wherein each of said elastomeric caps includes a raised circumferentialrib, said rib being sized and shaped to be snugly fit within one of saidopen chambers in said housing by abutting the cylindrical sidewall ofsaid open chamber.
 6. The apparatus of claim 5, wherein when said fluidhousing component is fit into said housing component, the contactbetween the raised circumferential rib and the cylindrical sidewall ofsaid open chamber into which the rib is fit forms a water-tight seal. 7.The apparatus of claim 1, wherein each piston is fit within said barrelso as to form a sealed fit about the outer circumference of the pistonand the interior wall of the cylindrical barrel.
 8. The apparatus ofclaim 7, wherein the generally flat proximal surface of said piston isaligned in a substantially flush configuration with the plungerreceiving end of the barrel into which the piston is disposed.
 9. Theapparatus of claim 1, wherein when said plunger component is secured tosaid fluid housing component, a first end of one of said pushing rodscontacts the proximal surface of one said piston.
 10. The apparatus ofclaim 1, wherein a biological fluid is placed within one of said barrelsand said biological fluid is contained within said barrel due to theseals created by the piston and elastomeric cap secured to said barrel.11. A method of dispensing at least two biological fluidssimultaneously, comprising the steps of: a. providing an applicatorcomponent, said applicator component comprising: i. a housing; ii. firstand second open chambers within said housing, each open chamber having agenerally cylindrical sidewalls and being aligned such that the centralaxes of each open chamber are parallel with each other; and iii. firstand second fluid lumens, each fluid lumen having an insertion end and adelivery end, said insertion end of the first fluid lumen comprising afirst needled cannula disposed within the first open chamber and theinsertion end of the second fluid lumen comprising a second needledcannula disposed within the second open chamber; b. providing a fluidhousing component, comprising: i. first and second cylindrical barrelseach having an open interior separated by a dispensing end and a plungerreceiving end; ii. first and second elastomeric caps, wherein the firstelastomeric cap is fit onto the dispensing end of the first cylindricalbarrel and the second elastomeric cap is fit onto the dispensing end ofthe second cylindrical barrel; iii. first and second pistons each havinga generally cylindrical configuration, with a sealing surface on theouter circumference and a generally flat proximal surface, the firstpiston being placed within the plunger receiving end of the first barreland second piston being placed within the plunger receiving end of thesecond barrel; iv. a bridge having an open interior, sized and shaped toreceive the dispensing ends of the first and second cylindrical barrelsand maintain the first and second cylindrical barrels in a substantiallyparallel configuration; c. providing a plunger component, comprising: i.first and second pushing rods each having a first end and second end,each sized such that the first end of a pushing rod may be inserted intothe plunger receiving end of a barrels; ii. an open flange componentthrough which said pushing rods may be slidably inserted; and iii. asecurement feature to secure the dispensing end of said first and secondbarrels in the open flange component. d. securing said applicatorcomponent to said fluid housing component, such that the first needledcannula pierces a the first elastomeric cap and the second needledcannula pierces a the second elastomeric cap; e. securing said plungercomponent to said fluid housing component; and f. depressing saidpushing rods, such that the first pushing rod moves the first piston inthe distal direction through the first barrel and the second pushing rodmoves the second piston in the distal direction through the secondbarrel, thereby forcing the first biological fluid through first fluidlumen and the second biological fluid through the second fluid lumen.12. The method of claim 11, wherein the delivery end of each lumen islocated substantially adjacent to each other, such that dispensing ofsaid first and second biological fluids simultaneously causes mixing ofsaid first and second biological fluids at the area of said deliveryends.
 13. The method of claim 11, wherein the fluid housing component issubjected to an electron beam processing step after said first andsecond fluid components are disposed within the first and secondbarrels.
 14. The method of claim 11, wherein each of said elastomericcaps includes a raised circumferential rib, said rib sized and shaped tobe snugly fit against the sidewall of one open chambers in said housing.15. A kit comprising the applicator component, fluid housing componentand plunger component of claim
 1. 16. The kit of claim 15, wherein saidfluid housing component comprises a first biological component within afirst barrel and a second biological component within a second barrel.17. A fluid housing cartridge for use in a modular delivery device,comprising: a. at least two cylindrical barrels having an open interiorseparated by a dispensing end and a plunger receiving end; b. at leasttwo elastomeric caps, wherein one elastomeric cap is fit onto thedispensing end of one cylindrical barrel; c. at least two pistons havinga generally cylindrical configuration, with a sealing surface on theouter circumference and a generally flat proximal surface, one pistonbeing placed into the dispensing end of one cylindrical barrel; d. abridge having an open interior, which fits securely on the dispensingend of said at least two cylindrical barrels so as to hold said at leasttwo cylindrical barrels in a substantially parallel configuration. 18.The fluid housing cartridge of claim 17, wherein said bridge includes akeyfit feature at a distal end of the bridge, said keyfit feature shapedand sized to mate with a keyfit feature of an applicator component. 19.The fluid housing cartridge of claim 17, wherein each of said pistons isplaced within the open interior of a barrel such that the generally flatproximal surface is substantially flush with the proximal end of thebarrel.
 20. The fluid housing cartridge of claim 17, wherein each ofsaid elastomeric caps includes an outwardly extending rib around itsouter circumference.